Tubulis GmbH is banking $22.75 million up front and could earn more than $1 billion in development, regulatory and commercial milestones from an alliance with Bristol Myers Squibb Co. focused on the design and development of antibody-drug conjugates for solid tumor applications. It would also receive tiered royalties on the sales of any products that emerge from the pact. Read More
Abdera Therapeutics Inc. emerged from stealth mode with $142 million in equity funding and plans to develop a pipeline of radiopharmaceutical drugs that will employ engineered heavy-chain-only antibody domains as targeting agents. It has already identified a lead, which targets delta-like ligand 3, a Notch pathway protein, which is overexpressed in about 80% of small-cell lung cancer cases, but which is absent from healthy tissue. A manufacturing campaign is now underway, and an IND submission is in the offing. Read More
With scientists yet to discover the specific antigen that confers protection from Epstein-Barr virus (EBV), there are currently no prophylactic vaccines available for the diseases it causes, the most well-known of which is infectious mononucleosis but which evidence suggests might also extend to immune disorders, multiple sclerosis and various cancers. This hasn’t stopped companies from trying, and one such player, EBViously Inc., is hedging its bets with a wider net, using as many proteins as possible to mimic the original viral pathogen and its complexity in a vaccine composed of non-infectious virus-like particles. Read More
China’s Hasten Biopharmaceutical Co. Ltd. will look for bolt-on acquisitions to deepen its pipeline following a funding round of $315 million that was co-led by Asia’s largest health care-dedicated investment firm, CBC Group of Singapore, and Abu Dhabi sovereign wealth fund, Mubadala Investment Co. Read More
The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years. Read More
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis. Read More
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. To date, China has 17 COVID-19 vaccine products that have completed or are in phase III trials, according to the NMPA. Read More
The U.S. Senate Finance Committee has its work cut out for it as it crafts bipartisan legislation “that will take on the worst practices by drug-pricing middlemen and ensure that the prescription drug supply chain is pulling in the same direction: more competition and lower costs for patients and taxpayers,” committee Chair Ron Wyden (D-Ore.) said. Read More
New and updated clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Beigene, Cellular Invlos, Karyopharm, Kinnate, Mapkure, Mendus, Mink, Nouscom, Relay, Repare, Scancell, Sonnet, Springworks, Transgene, Triumvira. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Cali, Ideaya, Leyden, Longeveron, Myrtelle, Nykode, Palleon, Revolo, Plus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Astellas, Blue Water, LG Chem, Moderna, Novartis, Sandoz, Senisca, Twist, Veru, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cel-Sci, CSL, Nascent, SAB, Taiho, Zucara. Read More
